Skip to content

ZenQMS for GxP Software Companies

“I just want a system that’s easy to use.”

We hear you. Many eQMS solutions complicate their process with needless rigidity. ZenQMS offers simplicity with configurable modules and common sense functionality. And GxP software companies can rest assured knowing we use our own software validation to support our critical-to-quality activities.

10-3
ClinOne Logo
ZenQMS supplies ClinOne with configurability, visibility, and speed
Fivos
ZenQMS’ cloud-based platform provides peace of mind to Fivos’ global teams

Access all modules from Day 1, including those critical to GxP Software Companies

DOCUMENTS MODULE

Create and automate workflows to match your current processes

  • Stay 21 CFR Part 11/ Annex 11 compliant for all electronic signatures
  • Automate and enforce workflows that match your current processes
  • Link related documents such as SOPs and forms
  • Search data, even within documents, using the Keyword Search feature
Updated doc-1-1
TRAINING MODULE

No more chasing down your team when training is due. Users get automated reminders of new and past-due assignments.

  • Easily create, complete, and track training from SOP reviews to on-the-job events.
  • Pull training reports by individual, course, or group.
ZenQMS Training Dashboard
CHANGE CONTROL MODULE

Configure your design control process to match your approach

  • Define and build your design control process rather than fitting into a vendor-supplied template
  • Import a traceability matrix configured to your preferences
  • Access and manage your design history file quickly and easily 
  • Handle document change requests, ECOs, and electronic batch records more efficiently
device change

The ZenQMS Difference

ZenQMS was built on the belief that, regardless of size, every Life Sciences organization should have access to the advantages that come with an electronic quality management system.

Easy-to-use Rather than force you into pre-designed templates, ZenQMS modules are fully configurable to match your current forms and processes. Familiarity makes things move a lot faster!
Easy-to-Implement Instead of an arduous 12-month process, we aim to have all clients up and running in 90 days, and often in less time than that. We want you to earn ROI as soon as possible!
Simple, Transparent Pricing From Day 1, you’ll receive access to every module for everyone on your team. We don’t believe in seat licenses, a la carte upselling, or long-term contracts. Do you?
Lifetime Support You deserve the best help. That's why our customer success team is completely in-house, there's no hourly charge for support, and our response time is measured in minutes.
Peace of Mind Our system is turn-key and fully managed/supported by ZenQMS-- meaning minimal IT resource needs to maintain it. The cloud-based, closed-loop system ensures data integrity, with guaranteed uptime of >99.99%.
Validation-ready The ZenQMS platform is fully validated for GxP per GAMP 5 guidelines for a Category 4 system. We are also ISO 9001:2015 and ISO 27001: 2013 certified, and HIPAA compliant.
Empathy We built our platform to identify and address the very same problems and frustrations we encountered as Quality Leaders ourselves. We know what you’re going through.
A Complete System Right from the start, you have access to all of our connected modules: Documents, Training, Issues, Change Control, and Audits. Implement them at your own pace.